Handheld portable examination device for diagnostic use

ABSTRACT

A portable medical examination device used for cancer detection using tissue illumination with radiation of a certain wavelength band to provide the operator with either reflected images of the tissue or by inducing visible fluorescence of the irradiated tissue. The medical examination device has an illumination source transmitting a light beam through a first lens unit to condition the light beam; a fiber optic bundle including an excitation fiber and an image fiber, wherein the excitation fiber delivers the conditioned light from the first lens unit to a tissue to be examined and wherein the image fiber directs the light emanating from the illuminated tissue to a second lens unit; and an angularly adjustable visualization unit, wherein a light beam conditioned by the second lens unit is visualized by the device operator and/or captured by an image capture device.

CROSS-REFERENCE TO RELATED APPLICATION

The present application, pursuant to 35 U.S.C. 111(b), claims thebenefit of the earlier filing date of provisional application Ser. No.61/063,755 filed Feb. 6, 2008, and entitled “Handheld PortableMicroscope for Diagnostic Use.”

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a portable apparatus for use in theidentification of cancer, in particular the identification of cancer onexternally exposed body surfaces.

2. Description of the Related Art

Spectroscopic screening and diagnostic apparatuses have been describedthat can evaluate tissues at a cellular level. These devices allow for aclose-up visual medical examination that can be performed in a doctor'soffice without having to rely on large sophisticated medical equipmentin a hospital or clinical setting. Optically based devices, such as theoptical needle biopsy device described in U.S. Publication No.2007/0173718, are advantageous in providing patient examinations withoutrelocation of the patient to a hospital or clinic and do not requirethat the patient make a separate appointment time. Furthermore, suchdevices eliminate or drastically reduce the multiple waiting periodsbetween the examination, removal, and diagnosis of questionable tissue.

One problem with the portable optical spectroscopic screening anddiagnostic devices previously described is that the optical probesdescribed are inflexible and difficult to use in examining internal bodycavities having limited access.

A need exist for a flexible portable probe having a selectablyadjustable angle for the operator to view the tissue being examined.

SUMMARY OF THE INVENTION

The present invention relates to a portable medical examination deviceused for cancer detection using tissue illumination with radiation of acertain wavelength band to provide the operator with either reflectedimages of the tissue or by inducing visible fluorescence of theirradiated tissue.

One embodiment of the present invention includes a medical examinationdevice for spectrally screening tissue for cancer having: anillumination source transmitting a light beam through a first lens unitto condition the light beam; a fiber optic bundle including anexcitation fiber and an image fiber, wherein the excitation fiberdelivers the conditioned light from the first lens unit to a tissue tobe examined and wherein the image fiber directs the light emanating fromthe illuminated tissue to a second lens unit; and an angularlyadjustable visualization unit, wherein a light beam conditioned by thesecond lens unit is visualized by the device operator.

A second embodiment of the present invention includes a medicalexamination device for the spectral detection of cancer having: anillumination source; a first lens unit conditioning a light beam fromthe illumination source; an excitation optic fiber delivering theconditioned light beam from the first lens unit to a tissue to beexamined; an image optic fiber receiving a light beam emanating from thetissue illuminated with the conditioned light beam and transmitting theemanated light beam through a second lens unit; and a lens supportassembly including a first lens holder, a mirror, and an ocular viewer,wherein the first lens holder is held in an aligned position that iscoaxially aligned with the second lens unit while the mirror and theocular viewer are angularly adjustable about the aligned position;whereby the emanating light beam passing through the second lens unit isdirected to the mirror and then to the ocular viewer.

Another embodiment of the present invention includes a medicalexamination device having: an illumination source; a first lens unitconditioning a light beam from the illumination source; an excitationoptic fiber delivering the conditioned light beam from the first lensunit to a tissue to be examined; an image optic fiber receiving a lightbeam emanating from the tissue illuminated with the conditioned lightbeam and transmitting the emanated light beam through a second lensunit; a beam splitter that splits the emanated light beam from thesecond lens unit into a first light beam and a second light beam; animage capture device for selectably capturing the first light beam; anda lens support assembly including a first lens holder, a mirror, and anocular viewer, wherein the first lens holder is held in an alignedposition that is coaxially aligned with the second lens unit while themirror and the ocular viewer are angularly adjustable about the alignedposition, and wherein the second light beam is directed to the mirrorand then to the ocular viewer.

The foregoing has outlined rather broadly several aspects of the presentinvention in order that the detailed description of the invention thatfollows may be better understood and thus is not intended to narrow orlimit in any manner the appended claims which define the invention.Additional features and advantages of the invention will be describedhereinafter which form the subject of the claims of the invention. Itshould be appreciated by those skilled in the art that the conceptionand the specific embodiment disclosed may be readily utilized as a basisfor modifying or designing of the structures for carrying out the samepurposes as the invention. It should be realized by those skilled in theart that such equivalent constructions do not depart from the spirit andscope of the invention as set forth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, and theadvantages thereof, reference is now made to the following descriptionstaken in conjunction with the accompanying drawings, in which:

FIG. 1 is a schematic representation of the principle components of theportable examination device.

FIG. 2A is an oblique rear view of the first embodiment of theinvention.

FIG. 2B is a rear view of the apparatus of FIG. 1.

FIG. 3 is a longitudinal cross-sectional view of the apparatus of FIG.2B taken on line 3-3.

FIG. 4 is an enlargement of a portion of FIG. 3, wherein the showing theillumination source and the first and second lens units with mountedfilters and lenses.

FIG. 5 is an oblique side view of a second embodiment of the apparatus.

FIG. 6 is a frontal view of the apparatus of FIG. 5.

FIG. 7 is a longitudinal sectional view of the apparatus of FIG. 6 takenalong line 7-7.

FIG. 8 is an oblique lateral view of a third embodiment of theapparatus.

FIG. 9 is an oblique view of the angularly selectably adjustable viewingsubassembly for the apparatus of FIG. 8.

FIG. 10 is a profile view from the lefthand side of the apparatus ofFIG. 8 with the lefthand housing removed in order to illustrate thearrangement of the interior components of the apparatus with theangularly selectably adjustable viewing subassembly coaxially aligned.

FIG. 11 is a longitudinal sectional view of the apparatus of FIG. 8taken on the vertical longitudinal midplane with the angularlyselectably adjustable viewing subassembly angularly offset.

FIG. 12 is an exploded oblique view of the angularly selectablyadjustable subassembly of the third embodiment apparatus of FIG. 8.

FIG. 13 is a plan view of the unexploded angularly selectably adjustablesubassembly of FIG. 12, wherein the subassembly is angularly offset.

FIG. 14 is a side profile view of the angularly selectably adjustablesubassembly of FIG. 13.

FIG. 15 is a front profile view of the angularly selectably adjustablesubassembly of FIGS. 13.

FIG. 16 is a longitudinal vertical cross-sectional view of the angularlyselectably adjustable subassembly of FIG. 13.

FIG. 17 is a side profile view of the angularly selectably adjustablesubassembly with the subassembly coaxially aligned, rather thanangularly offset.

FIG. 18 is a lateral profile view of a fourth embodiment of theexamination device.

FIG. 19 is a lateral profile view of the apparatus of FIG. 18 with therighthand housing removed.

FIG. 20 is a longitudinal vertical cross-sectional view of the apparatusof FIG. 18.

FIG. 21 is an oblique exploded view of the apparatus of FIG. 18.

FIG. 22 is a longitudinal sectional view of the beam splitter assemblywith a filter mounted on the entry port, wherein the beam splitterpermits both electronic imaging and simultaneous direct viewing of thelight beam reflected or fluoresced by the sample.

FIG. 23 is a longitudinal sectional view of the beam splitter assemblysimilar to that of FIG. 22 but with a filter mounted on the exit port.

FIG. 24 is a longitudinal sectional view of the beam splitter assemblysimilar to that of FIG. 23 but with a filter mounted on the CCD port.

FIG. 25A is a longitudinal sectional view of the disposable sheath forthe first embodiment having an angled distal tip.

FIG. 25B is a longitudinal sectional view of the disposable sheath forthe first embodiment with an optical coupler incorporated in the distaltip.

FIG. 25C is a longitudinal sectional view of the disposable sheath forthe second embodiment having a vertically transverse distal tip.

FIG. 25D is a longitudinal sectional view of the disposable sheath forthe second embodiment with an optical coupler incorporated in the distaltip.

FIG. 26 is similar to FIG. 4 showing the illumination source and thefirst and second lens units with a single filter in each.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As a note, the use of the terms “invention”, “present invention” andvariations thereof throughout the subject patent application (andheadings therein) are intended to refer or relate to one or moreembodiments of the present application, not necessarily every embodimentor claim of the application.

This invention pertains to a compact practical diagnostic apparatus forusing portable optical microscopic means to examine biological tissue insitu in a clinical environment. Specifically, the portable examinationdevice of the present invention is used to visually identify cancers orother abnormal cells in a specimen. The cancers which may be identifiedusing the apparatus of the present invention are located on externallyexposed, surgically exposed, or accessible interior surfaces of the bodyof a patient. The configuration of the apparatus may be specificallyarranged depending on the anatomical location of potential cancer oruser preference.

The portable examination device can be used for cancer diagnosis byusing tissue illumination with radiation of a certain wavelength band toprovide the operator with either reflected images of the tissue or byinducing visible fluorescence of the irradiated tissue. Use of acontrast agent applied to the tissue can enhance the optical evaluationof tissues.

As illustrated in FIG. 1, the diagnostic apparatus has an illuminationsource 1, a visualization unit 4, an optical probe or fiber optic wand3, and a power supply 1. These basic components may be implemented in avariety of embodiments and can be packaged in a number of configurationswithout departing from the scope of the invention as set forth in theclaims.

Four embodiments of the apparatus are shown, with each embodimentarranged to satisfy particular needs. The first embodiment is configuredso that the apparatus can be brought adjacent a specimen with the axisof the instrument angularly inclined from the specimen surface.

The second embodiment is similar to the first embodiment, but isconfigured so that the apparatus is perpendicular to the surface of thespecimen. Both the first and second embodiments are powered by externalelectrical power.

The third embodiment is characterized by internal battery power and anability to selectably rotate the viewing eyepiece to a more easilyviewed position without rotating the entire apparatus.

The fourth embodiment is similar to the third, but is also providedmeans for electronically capturing images for display on a screen or forelectronic storage.

The materials of construction for structural components are typicallystainless steel and plastics such as nylon, ABS, fiberglass, andpolypropylene. The lenses for the device are generally glass orpolycarbonate plastic. A light-emitting diode (LED) is typically used toprovide illumination, and insulated copper wiring and connectors aregenerally used for the transmission of electrical power.

Referring now to the drawings, it is noted that like referencecharacters designate like or similar parts throughout the drawings. Thefigures, or drawings, are not intended to be to scale. For example,purely for the sake of greater clarity in the drawings, wall thicknessesand spacings are not dimensioned as they actually exist in the assembledembodiments.

I. Basic Components of the Apparatus

The Illumination Source

One of the basic components of the medical examination device is theillumination source 1. The illumination source includes a lamp andoptional lenses and filters.

The lamp is preferably one or more LEDs (light emitting diodes), whileother embodiments include an Xenon or Mercury arc lamp, a Helium Cadmiumlaser, a halogen lamp, and the like. One embodiment of the device uses aplurality of selectable LEDs. Since LEDs are available that emit avariety of colors or emitted wavelength bands, the use of one or moreLEDs can be used to provide the desired wavelength band of the lightbeam emitted.

Although not required, the light from the illumination source istypically conditioned and/or filtered with optical lenses and filters toobtain the desired wavelength band for the light beam used for themedical examination. The light is optionally conditioned or filteredusing either one or more selected lenses or filters. If the light beamis to be conditioned using a lens and/or a filter, the lens or filter ispositioned between the lamp emitting the light beam and the fiber opticwand that directs the light to the tissue to be illuminate such as inthe first lens unit 60.

The first lens unit 60 may have no filter/lens, or it may have anynumber of filters and/or lenses for conditioning the illumination lightbeam. Examples of such lenses/filters include, but are not limited to, apolarizing filter, a neutral density filter, a fluorescent filter,and/or a collimating lens. The embodiment illustrated in FIG. 26utilizes a single filter/lens 130; whereas the embodiment shown in FIGS.3 and 4 uses both lenses and a conditioning filter to prepare the lightused to illuminate the tissue 5.

Fluorescent and/or reflectance spectra are typically used tocharacterize the pre-cancerous or cancerous condition of the tissuebeing examined. One or more excitation fluorescence bandwidths may beused, such as 455-465 nm, 410-430 nm, 375-385 nm and/or 340-360 nm, toexcite the tissue. Similarly if reflectance is used to examine thetissue, then white light (400-700 nm), or narrower bands such as 455-465nm, 410-430 nm or 550-590 nm may be used to illuminate the tissue.Parallel and/or cross-polarized light may also be used to enhancedifferent tissue structures.

The Visualization Unit

The visualization unit 4 includes an ocular viewer, optional lenses andfilters, an angularly rotatable viewing subassembly, and an optionalimage capture device, such as an electronic digital camera fordisplaying, capturing and storing reflectance and/or fluorescence imagesof the illuminated tissue 5.

The light beam from the illumination source 2 impinges on the tissue tobe examined. The light beam emanating from the illuminated tissue sample5 is optionally filtered or conditioned by a second lens unit 65 beforebeing directed to an ocular viewer and/or a camera for recording.

The second lens unit 65 may have no filter/lens, or it may have anynumber of filters and/or lenses for conditioning the light beamemanating from the illuminated tissue. Examples of such lenses/filtersinclude, but are not limited to, a polarizing filter, a neutral densityfilter, a fluorescent filter, and/or a collimating lens. The embodimentillustrated in FIG. 26 utilizes a single filter/lens 120; whereas theembodiment shown in FIGS. 3 and 4 uses both lenses and a conditioningfilter to prepare the light used to illuminate the tissue 5. In oneembodiment the second lens unit 65 blocks substantially all of thewavelengths in the beam of light selected by the first lens unit 60.

The nature of the emanating light beam will depend on the nature of theimpinging light beam. For example, if the impinging light beam is whitelight, then the returning light beam is reflected light. Alternatively,if the light beam is fluorescent light that impinges on the surface ofthe tissue 5 causing it to fluoresce, then the returning light beam willbe the resultant fluorescence from the tissue 5.

The embodiment of the visualization unit 2 illustrated in FIGS. 8-11includes an operator angularly adjustable viewing subassembly 250. Thelight beam emanating from the illuminated tissue 5 is directed throughthe second lens unit 65 to a mirror 310 mounted in a lens supportassembly 240 which allows the light beam impinging on the mirror 310 tobe directed to the ocular viewer 90 when the viewing lens 90 has beenadjusted to a variety of angles from the axis of the image receivingfiber or the second lens unit.

The lens support assembly includes a first lens holder, a mirror, and anocular viewer. The first lens holder is held in a position that iscoaxially aligned with the image receiving fiber or the second lens unitwhile the mirror and the ocular viewer are angularly adjustable. Theocular viewer is angularly adjustable up to a 90° angle from the axis ofthe second lens unit.

The embodiment of the visualization unit 2 illustrated in FIGS. 20-22includes an image capture device, such as a CCD imaging device. Thefluorescence or reflected light from the tissue 5 is returned in a beam491 to the visualization unit 2. This embodiment of the visualizationunit 2 passes the light beam 491 through a beam splitter assembly 470.Examples of a beam splitter include without limitation a dichroicmirror, a half silvered mirror, or a polarization beam splitter. Thebeam splitter assembly 470 allows the tissue image to be visually seenby the operator through the ocular device while a reflected image isavailable to be photographed or captured by the CCD imaging device.

The Fiber Optic Wand

The fiber optic wand or optical probe 3 provides a microscopic view of aspecific site on the tissue 5. The fiber optic wand 3 is a contactingoptical probe that delivers a light beam to the tissue 5 via an array ofmultiple fiber optic excitation strands or fibers and collects theemanated light from the tissue with one or more fiber optic collectionstrands or fibers. Preferably, multiple collection or image fibers areused, where the image fibers are in a coherent bundle. A coherent bundleof image fibers have the same spatial organization at the both itsproximal and distal ends. Throughout the description herein the term“image fiber” refers to a coherent bundle of image fibers.

One embodiment of the fiber optic wand or optical probe 3 describedherein is shown in FIGS. 5, 7, and 8. The probe has a shaft with adistal end for placing on a tissue site 5 to be examined. The probeshaft extends from the distal end of the portable examination devicehousing. A continuous bi-directional fiber optic bundle 171 runs throughthe probe shaft to the distal end of the shaft. The fiber optic assembly70 or 170 may be constructed with any number of excitation fibers andcollection fibers in a variety of configurations. For example, theexcitation fibers may be located around the periphery of the image fiberbundle.

The fiber optic wand or optical probe 3 has an optional disposablesheath 76 or 176 for isolating the distal end of the shaft and/or thefiber optic bundle from the tissue sample, when the portable examinationdevice is to be used in the clinic. The distal tip 77 or 177 of thesheath is used to contact the tissue specimen of interest.

The distal tip 77 or 177 of the disposable sheath may have an opticalcoupler or lens for optically conditioning the light. FIG. 25Billustrates an optical coupler 78 in the distal tip 77 of the sheath 76,whereas FIG. 25D illustrates an optical coupler 178 in the distal tip177 of the sheath 176. When the optical conditioning assembly or opticalcoupler 78 or 178 is present at the distal tip of the sheath, theoptical coupler contacts the tissue specimen of interest.

The sheath 76 or 176 and/or its distal tip 77 or 177 is constructed of amaterial that is non- or minimally light scattering and transparent tothe emitted wavelength band of light used for the spectrographicinvestigation and any reflected or fluorescent light passing back intothe wand from the tissue 5. In addition, the material should generateminimal autofluorescence.

It should be noted here that when the disposable sheath 176 ispositioned on the fiber optic wand 3 that it is considered a part of theprobe and the distal end 177 of the sheath 176 becomes the distal end ofthe probe 3.

The Power Supply

The power supply 1 for the medical examination device may either be arechargeable battery pack or supplied through an electrical cord. FIG. 1shows one embodiment of the power supply 1 and its interaction with theillumination source of the portable examination device. The power supply1 may also be used to power an image capture device such as acharge-coupled device (CCD) so that the image can be stored, enlarged,viewed and/or spectrally analyzed on a separate external device such asa viewer or computer.

The power supply 1 regulates output voltages and currents for theillumination source 2 and/or the image capture device.

II. First Embodiment of the Apparatus

FIGS. 2 to 4 illustrates the first embodiment 10 of the portableexamination device in an oblique rear view, a rear view, a longitudinalcross-sectional view, and a detail view, respectively.

The primary components of the first embodiment portable examinationdevice 10 consists of a housing 11, a power supply 40, an illuminationsource or LED 57, a fiber optic wand assembly 70, lenses and opticalfilters in a lens mounting block 50, and an ocular viewing device orlens 90. The housing 11 is made of righthand and lefthand molded plastichousing halves 12 and 22, respectively. Except as noted, the two housinghalves 12 and 22 are mirror-image parts which surround the internalcomponents of the apparatus 10.

Details of the lefthand housing half 22 are shown in FIGS. 3 and 4. Thelefthand housing half is a thin wall body with a vertical outer walloffset from the midplane of the housing assembly and a perpendicularperipheral wall extending normal to the midplane of the housing assembly11. Housing half 22 has a vertical planar mating face comatable with acorresponding face for righthand housing half 12 at the midplane of thehousing assembly. The perpendicular peripheral wall of housing half 22has a horizontally elongated perimeter wall having a rear verticaltransverse end, an intermediate vertical transverse diaphragm 27, avertical transverse forward end, and parallel upper and lower sides. Theheight of the lefthand housing half 22 is reduced at its forward end byinclined flat transition sections. Offset from the mating face of thelefthand housing half 22 is a flat outer wall connected to theperpendicular peripheral wall. The distance between the mating face andthe outer wall is less than the height of the lefthand housing half.

On the lower side of both housing halves 12 and 22 are locatedsemicircular cutouts 13 and 23, respectively, which serve as power cordopenings. As seen in FIG. 3, lefthand housing half 22 has a semicircularcutout wand opening 24 on its forward vertical end which mounts anelastomeric grommet 75 which serves to centralize the fiber optic wand70 where it passes out of the housing 11. On the rear vertical end ofthe housing half 22 is located a semicircular cutout view port opening25 for mounting an ocular eyepiece lens 90 and an elastomeric eye cup 91on the midplane of the housing 11. All of the semicircular cutouts 13,23, 24, and 25 have the axes of the semicircles on the mating plane ofthe housing halves 12 and 22.

The lefthand housing half 22 has on the inner side of its peripheralwall multiple alignment bosses 26 which extend horizontally past thevertical mating face of the housing half but which do not extend beyondthe inner side of the peripheral wall in an outward direction. Thesealignment bosses 26 serve to maintain alignment between the two housinghalves 12 and 22. Alignment bosses 26 represent the only departure frommirror imagery for the two housing halves 12 and 22.

The vertical transverse bulkhead 27 of housing half 22 is provided withhorizontal axis semicircular cutouts 28 and 29 which have their axes onthe mating plane of the housing half. Cutout 28 serves as a locator andpassageway for the image fiber bundle 72 and cutout 29 serves the samepurpose for the main fiber bundle 71 of the fiber optic assembly 70.

Corresponding coaxial horizontal holes penetrate the vertical outerwalls of both the righthand 12 and lefthand 22 housing halves. Thesecoaxial holes permit the housing screw 86 to extend through both holesand to there engage housing nut 87 so that the housing halves can beassembled into alignment and clamped together.

The power supply 40 for the first embodiment 10 consists of arectangular prismatic block having first 41 and second 42 parallel butlaterally offset power prongs projecting normally from one side. Thepower prongs 41 and 42 are configured for connective engagement into astandard 120 volt AC wall socket. The power supply block containsconversion means for rectifying and stepping down the AC wall plugvoltage to a DC current suitable for the operation of the illuminationsource. Power cord 43 containing a first power conductor 45 and a secondpower conductor 46 connects the power supply 40 and the illuminationsource. The illumination source 2 is preferably one or more LEDs (lightemitting diodes), although other embodiments include a Xenon or Mercuryarc lamp, a Helium Cadmium laser, or a halogen lamp. The illuminationsource shown in FIG. 3 is typically an LED light source 57. Grommet 44,mounted on power cord 43, serves to support the power cord and limitit's bending where it is engaged with the lens mounting block 50, asseen in FIG. 3.

Lens mounting block 50 is typically either a metallic or molded plasticbody symmetric about its vertical midplane, which is located on themating plane of the housing halves 12 and 22. The external surface oflens mounting block 50 is composed of rectangular prismatic elements.From the rear end, lens mounting block 50 has a vertically thin flatelement projecting forward to support an upwardly extending lower blockwhich in turn mounts another upwardly extending but longitudinallyshorter upper block 53. The front vertical faces of the lower and upper53 upwardly extending blocks are flush. On the centerline of thehorizontal thin flat element of the lens mounting block 50 is avertically extending hole which serves as a power cord opening 51 forsupporting grommet 44 of the power cord 43.

An upwardly opening rectangular cavity extends into the upper face ofthe lower upwardly extending block to the level of the upper surface ofthe thin flat element of the block, thereby creating vertical transversebulkhead 52 on the rear face of the lower upwardly extending block. Theforward vertical face of the upwardly opening cavity is flush with therear face of the upper block 53. The transverse bulkhead 52 ispenetrated by a small horizontal axis hole which is coaxial with alarger first lens mounting bore 54. The hole in the transverse bulkhead52 provides a passage for the first 45 and second 46 conductors of thepower cord 43.

The first lens mounting bore 54 extends forward from the forward side ofthe upwardly opening cavity to penetrate the lower upwardly extendingblock. A similar second lens mounting bore 55 is vertically offset topenetrate the upper block 53. A transverse retention screw hole 56penetrates the lens mounting block 50 between the first 54 and second 55lens mounting bores.

A LED light source 57 having integral lens 58 is mounted on the forwardside of the transverse bulkhead 52 concentric with the first lensmounting bore 54 of the lens mounting block 50. The first conductor 45and the second conductor 46 of the power cord 43 are attached to therear face of the LED 57 to power the LED.

A first lens unit 60 is mounted in the first mounting bore. The firstlens unit 60 includes a lens mounting tube 61 and an optional number oflenses and/or filters to condition the light from the LED 57. The firstlens unit 60 may only contain a neutral density filter, so that it doesnot affect the light beam 81 passing through it. However, it is morecommon for the lens unit 60 to contain one or more filters and/or lensesas illustrated in FIG. 26 and FIG. 4. One example of the first lens unit60, shown in FIG. 4, includes a first lens 62, a second lens 63, and anoptical filter 64.

The lens mounting tube 61 is a horizontal axis thin wall tube which hasan outwardly projecting flange on its forward end. The outer cylindricalsurface of the tube 61 is a close fit to the first lens mounting bore 54of the lens mounting block 50. The first lens 62, the second lens 63 andthe filter 64 all have the same outer diameter which is a close fit tothe bore of the tube 61 in which they are mounted. From the rear andextending in the forward direction, the mounting of components in themounting tube 61 is the first lens 62, the second lens 63, and then thefilter 64.

The second lens unit 65 is similar to the first lens unit 60 andincludes a lens mounting tube 61 and any number of filters and/or lensesdesired. Although the second lens unit may only contain a neutraldensity filter, it will more likely contain at least one lens and/orfilter. For example the second lens unit 65 illustrated in FIG. 4includes a first lens 66, a second lens 67, an optical filter 68, and athird lens 69.

The outer cylindrical surface of the tube 61 is a close fit to thesecond lens mounting bore 55 of the lens mounting block 50. Lenses 66,67, 69, and filter 68 all have the same outer diameter which is a closefit to the bore of the tube 61 in which they are mounted. From the rearand extending in the forward direction, the mounting of components inthe mounting tube 61 of second lens unit 65 is the first lens 66, thesecond lens 67, the filter 68, and then the lens 69. Both the first 60and second 65 lens units are inserted into their respective mountingbores 54 and 55 until their mounting tube flanges are flush with theforward vertical face of the lens mounting block 50.

The fiber optic assembly 70 of the first embodiment consists of a shaftand a straight cylindrical main fiber optic bundle 71 having a number ofindividual excitation fibers and at least one image receiving fiber 72.The image receiving fiber 72 is typically a coherent fiber bundle thatexits the main fiber optic bundle 71 and is vertically offset from theaxis of the main bundle at its rearward end.

At its forward end the image receiving fiber 72 is bent to enter themain fiber optic bundle 71 and is typically placed in a central positionwithin the main fiber optic bundle 71 at its forward end. The diameterof the image receiving fiber 72 is often larger than the excitationfibers in the main bundle 71. The distal (forward) end of the mainbundle 71 with its centrally located image receiving fiber 72 has aplanar cut symmetrical about the vertical midplane so that its lowerfibers are shorter than its upper fibers. This angular probe and imagereceiving fiber or fiber bundle 72 is advantageous in that any specularreflection from the interface is directed away from the collector pathand the image fiber bundle 72. Such specular reflection is caused by animperfect contact between the tissue and the distal end of the probe orsheath due to an uneven tissue surface, as well as a difference in theindex of reflectance between the tissue and the distal tip of theprobe/sheath.

A grommet 75 is deployed around the shaft of the fiber optic assembly 70on the forward side of the junction of the image receiving fiber 72 andthe main fiber optic bundle 71. The engagement of the grommet 75 withthe semicircular wand opening 24 and the engagement of the main bundle71 with the main fiber opening 29 of the lefthand housing half 22locates and aligns the fiber optic assembly 70 relative to the housing11. Additionally, the close fit of the image receiving fiber 72 with thesemicircular image fiber opening 28 of the housing half 22 aligns andstabilizes that fiber relative to the housing 11. Although not shownherein, the corresponding cutouts in the antisymmetric righthand housinghalf 12 serve to perform the same alignment and positioning functions asthe cutouts of the lefthand housing half 22.

When in clinical use, a close fitting transparent disposable plasticsanitary sheath 76 having a thin distal end is interposed over distalend of the shaft of the fiber optic assembly 70 for sanitary reasons.The closed outer end of the sanitary sheath 76 has a uniform thicknessplanar face having the same angular orientation as that of the distaltip of the main fiber optic bundle 71.

The distal tip 77 of the sanitary sheath 76 is used to contact thetissue 5 to be examined. The distal tip may have a lens/filter oroptical coupler 78 inset in the distal tip 77 of the sheath 76. Theplastic of the disposable sanitary sheath 76 is selected so that it istransparent to both the emitted wavelength band of light used for theillumination of the specimen and any reflected or fluoresced lightcoming from the irradiated specimen.

An eyepiece ocular lens 90 and an elastomeric eye cup 91 are mounted atthe rear transverse face of the housing 11 by means of their engagementwith the semicircular cutout view port opening 25 in the lefthandhousing half 22. As before, the corresponding cutout in theantisymmetric righthand housing half 12 coacts with the opening 25 tocentralize the lens 90 and eye cup 91 so that they are coaxial with theexposed interior end of the image receiving fiber 72 of the fiber opticassembly 70.

III. Second Embodiment of the Apparatus

A second embodiment 100 of the portable examination device is seen inuse in an oblique side view in FIG. 5, a frontal view in FIG. 6, and alongitudinal sectional view in FIG. 7. The second embodiment portableexamination device 100 primarily consists of a housing 11, a powersupply 40, an illumination source such as the laser light source 157, afiber optic wand assembly 170, lenses and optical filters in a lensmounting block 50, and an ocular viewer 90.

As with the first embodiment 10, the housing 11 is made of righthand andlefthand molded plastic housing halves 12 and 22, respectively. Exceptas noted previously, the two housing halves 12 and 22 are mirror-imageparts which surround the internal components of the apparatus 100.Furthermore, the mounting of the components of the second embodiment 100is the same as for the first embodiment 10.

The fiber optic assembly 170 is substantially similar to fiber opticassembly 70 of the first apparatus embodiment 10, with the exceptionthat the forward end of the fiber optic bundle 171 has a transverse cutso that the end is vertical. To accommodate this change, the forward endof the sanitary sheath 176 is perpendicular to the axis of the sheath,so that the specimen contact surface 177 is perpendicular.

Accordingly, the second portable examination device embodiment 100 isfunctionally and structurally substantially similar to the firstembodiment 10, with the exception of a transverse distal end of the mainfiber optic bundle 171 and the image fiber 172.

IV. Third Embodiment of the Apparatus

The third embodiment portable examination device 200 is shown in anoblique view in FIG. 8, a left side profile view with the lefthandhousing half 222 removed in FIG. 10, and in a longitudinal sectionalview in FIG. 11. FIGS. 9 through 17 show details of a mechanism includedin the third embodiment to permit the user of the examination device 200to change the orientation of the user viewing axis relative to the axisof the fiber optic assembly 170.

The third embodiment portable examination device 200 primarily consistsof a housing 211, a battery power source 230 with an operator selectableon-off switch 207, a light-emitting diode (LED) light source 57, a fiberoptic wand assembly 170, lenses and optical filters in a lens mountingblock 450, and a selectably angularly adjustable rotatable viewingsubassembly 250.

With the exception of the use of battery power and modificationsenabling provision of the rotatable viewing subassembly 250, the thirdembodiment portable examination device 200 is functionally andstructurally similar to the second embodiment 100. The third embodiment200 of the portable examination device uses many of the similarcomponents as does the second embodiment 100. As with the first andsecond embodiments 10 and 100, the housing 211 is made of righthand andlefthand molded plastic housing halves 212 and 222, respectively. Exceptas noted below, the two housing halves 212 and 222 are mirror-imageparts which surround the internal components of the apparatus 200.

Details of the righthand housing half 212 are shown in FIGS. 10 and 11.The righthand housing half 212 is a thin wall body with a vertical outerwall offset from the midplane of the housing assembly and aperpendicular peripheral wall extending normal to the midplane of thehousing assembly 211. Housing half 212 has a vertical planar mating facecomatable with a corresponding face for lefthand housing half 222 at themidplane of the housing assembly. The perpendicular peripheral wall ofhousing half 212 has a horizontally elongated upper and lower perimeterwalls having a rear opening, an intermediate vertical transversediaphragm 217, and a vertical transverse forward end.

The height of the righthand housing half 212 is reduced at its forwardend by inclined flat transition sections, with the upper flat transitionsection extending approximately 40% of the length of the housing half.In the midsection of the righthand housing half 212, the upper and lowerperipheral wall surfaces are parallel and horizontal. At its rear end,the upper and lower peripheral wall surfaces are also parallel, but areinclined upwardly towards the rear.

Offset from the mating face of the righthand housing half 212 on itsforward section is a flat outer wall connected to the perpendicularperipheral wall. The distance between the mating face and the outer wallis less than the height of the righthand housing half. As can be seenbest in FIG. 8, the righthand housing half 212 is widened toward therear from the junction of the horizontal portion to the rearwardlyupwardly inclined portion of the upper and lower peripheral walls.

The rearward section of the housing 211, consisting of about one thirdof its length, has a vertical outer wall which is parallel to but offsetmore from the vertical housing midplane than the forward end of thehousing. The rearward section of the vertical outer wall is arcuate withthe axis of the arc horizontal and perpendicular to the midplane of thehousing. Coaxial with the axis of the arc on the rearward section of thevertical outer wall is a transverse circular guide bore opening 213. Therearmost section of the vertical outer wall extends farther to the rearthan do the upper and lower peripheral walls of the righthand housinghalf 212.

As seen in FIGS. 10 and 11, righthand housing half 212 has asemicircular cutout wand opening 214 on its forward vertical end whichmounts an elastomeric grommet 75 which serves to centralize the fiberoptic wand 170 where it passes out of the housing 211. On the upperhorizontal side of the housing half 212 is located a rectangular cutoutfor accommodating the on/off switch 207 for the electric power.

Although not shown herein, the lefthand housing half 222 can have on theinner side of its peripheral walls multiple alignment bosses whichextend horizontally past the vertical mating face of the housing halfbut which do not extend beyond the inner side of the peripheral wall inan outward direction. These alignment bosses can serve to maintainalignment between the two housing halves 212 and 222. Any alignmentbosses would represent the only departure from mirror imagery for thetwo housing halves 212 and 222.

The vertical transverse bulkhead 217 of housing half 212 is providedwith horizontal axis semicircular cutouts 209, 218, and 219 which havetheir axes on the mating plane of the housing half. Cutout 218 serves asa locator and passageway for the image fiber 172 and cutout 219 servesthe same purpose for the main fiber bundle 171 of the fiber opticassembly 170. Cutout 209 serves as a passage for one or more batterycables 231. All of the semicircular cutouts 214, 209, 218 and 219 havethe axes of the semicircles on the mating plane of the housing halves212 and 222.

Bosses are provided on the interior vertical faces of the flat outerwall to locate internal components housed within the housing 211. Forrighthand housing half 212, inwardly projecting boss 202 locates switch207, multiple bosses 203 locate the battery 230, and a low height boss204 extends inwardly above the interior horizontal lower wall of housing212 to locate the lens mounting block 450. Additionally, two restrainingbosses 216 project from the interior vertical wall towards the housingmidplane symmetrically positioned about a horizontal plane passingthrough the axis of guide bore opening 213. The bosses 216 closely fitaround the upper and lower edges of the first righthand link 262 of thelens support assembly 240 of the rotatable viewing subassembly 250,thereby locating that assembly. The corresponding bosses of the lefthandhousing half 222 likewise closely engage the upper and lower edges ofthe first lefthand link 278 of the lens support assembly 240 of therotatable viewing subassembly 250.

Corresponding coaxial horizontal holes penetrate the vertical outerwalls of both the righthand 212 and lefthand 222 housing halves. Thesecoaxial holes permit the housing screw 86 to extend through both holesand to there engage housing nut 87 so that the housing halves can beassembled into alignment and clamped together.

The battery 230 is a rectangular prism which has terminals on its rearface. Battery cables 231 are connected to the battery on their firstends and to the switch 207 on their second ends. Switch 207 is a doublethrow two-position slide switch with its switch handle projectingupwardly through rectangular notches in the housing halves 212 and 222.LED power cables 208 extend from the switch 207 to the LED 57. Thebattery 230 is located within the housing 211 by the multiple bosses 203of the righthand housing half 212 and the corresponding bosses on themirror-image lefthand housing half 222.

The lens mounting block 450 for the third embodiment 200 issubstantially similar to the lens mounting block 50 used for the firsttwo embodiments 10 and 100, with the exception of the shortening of therearwardly projecting vertically thin element and the elimination of thepower cord opening 51.

The lens mounting block 450, like the lens mounting block 50, mounts theLED 57 with its integral lens 58 and the first lens unit 60 and thesecond lens unit 65. The lens mounting block 450 is supported andlocated on its lower side by the boss 204 and is further restrained bythe passage of clamping screw 86 through its central transverse hole.

The fiber optic assembly 170, the grommet 75, and the sanitary sheath176 of the second embodiment 100 are all used with the third embodiment200 and are located in the same manner as in the second embodiment, withrestraint and location being provided by the wand opening 214, the imagefiber opening 218, and the main fiber optic bundle opening 219 of therighthand housing half 212 and the corresponding openings of thelefthand housing half 222.

Referring to FIG. 9, the rotatable viewing assembly 250 of the thirdembodiment 200 is seen in an oblique view from its forward lower leftside. The rotatable viewing subassembly 250 is housed withinmirror-image righthand 251 and lefthand 255 covers. For ease ofdescription, only the lefthand cover 255 is described herein.

As seen in FIG. 10, the cover 255 is a thin wall plastic or metalstructure having, when seen from the outside looking normal to thevertical midplane of symmetry, a planar outer face with a circularlyarcuate rounded forward end and a low height round boss 256 concentricwith the arcuate forward end. The round boss 256, corresponding to theround boss 252 in the righthand housing half 212, is a slip fit to theguide bore opening in the lefthand housing half 222 corresponding to theopening 213 in the righthand housing half 212.

On the rear side, the planar outer face has a radially protrudingextension having a vertical rearward side perpendicular to andsymmetrical about a horizontal radius emanating from the center axis ofthe arcuate forward end. The radially protruding extension has ahorizontal top edge, while its lower edge is tangent to the arcuateforward end.

A peripheral end wall extends between the planar outer face of cover 255and the mating vertical midplane of the righthand 251 and lefthand 255covers. As seen in FIG. 9, the peripheral end wall is not continuous,but has a cutout extending from slightly below the horizontal midplaneto considerably above the horizontal midplane. The horizontal lower edge254 of the cutout is positioned to just clear the lower side of the lenssupport assembly 240 when the rotatable viewing assembly 250 isstraight, while the horizontal upper edge 259 of the cutout ispositioned to just clear the upper side of the lens support assemblywhen the rotatable viewing assembly is at its maximum rotation position.The latter case is seen in FIG. 9.

The transverse end face 253 of the lefthand cover 255 is provided with arectangular cutout having its axis on both the mating midplane and theaxis of the arcuate rounded forward end of the lefthand cover 255. Thecutout accommodates a lens housing 260 of the lens support assembly 240.Mounting screw holes are provided in the transverse end face 253 for theattachment of the flange 261 of a lens housing 260.

The lens support assembly 240, shown in FIG. 12, is a pivoting doublysymmetrical linkage which supports a central mirror 310. Reflection ofan incoming light beam by the mirror causes the outgoing light beam tobe deflected.

The linkage consists of mirror-image righthand and lefthand halves, withthe righthand half having both a first 262 and a second 268 righthandlink. Likewise, the lefthand half has corresponding first 278 and second273 lefthand links. The first righthand link 262 and the first lefthandlink 278 support a first tubular lens housing 260, while the secondrighthand link 268 and the second lefthand link 273 support a secondtubular lens housing 260. Besides being cojoined by the lens housings260, the two sides of the lens support assembly 240 are joined in themiddle by a mirror carrier 285.

The tubular lens housing 260 consists of a thin wall right circularcylindrical tube having a coplanar transverse pair of flanges slightlyoffset from a first end which has a small outwardly projectingtransverse rim flange. The flanges of the tubular lens housing 260 eachhave mounting holes 308 engageable by screws 312 for mounting the lenshousing 260.

The first lens housing 260, shown on the right side of FIG. 12, containsin sequence from its nonflanged end a first receiving lens 301, a secondreceiving lens 302, and a third receiving lens 303. The second lenshousing 260, shown on the left side of FIG. 12, contains the ocular lens90 and mounts elastomeric eyecup 91 on its externally protruding annularrim flange.

Referring to FIG. 12, the first righthand link 262 is a flat metalstamping having a first end with a transverse circular pivot hole 263, astraight lower edge, and an outwardly bent flange 264 perpendicular tothe lower edge at a second end. The distance from the straight loweredge to the pivot hole 263 is half of the height of the flange 264. Theflange 264 is provided with two mounting holes 265 for permittingattachment of a tubular lens housing 260. Parallel to and locatedadjacent the side of the link 262 opposed to the straight lower edge isan elongated reaction slot 266 which has a close sliding fit to atraveling pin 293. The first lefthand link 278 with its end flange 279is a mirror image of the first righthand link 262.

The second righthand link 268 is constructed similarly to the firstrighthand link 262 in having a pivot hole 271, an end flange 269 withmounting holes 270, and a reaction slot 272. Second righthand link 268is a mirror image of first righthand link 262, except that the flange269 extends outwardly more and the holes are offset more from the flatmain portion of the stamping in order to accommodate mounting a secondtubular lens housing when the second righthand link 268 is inwardly setrelative to the first righthand link 262 in the lens support assembly240. The second lefthand link 273 with its end flange 274 is a mirrorimage of the second righthand link 268.

The mirror carrier 285 is a sheet metal stamping symmetrical about botha midplane corresponding to the midplane of the lens support assembly240 and a second plane transverse to the midplane. Seen looking down theapparatus midplane, the mirror carrier 285 has a flat rectangularcrosspiece 289 transverse to the midplane, with mirror image parallelplanar sides equally offset from the midplane. Offset from thecrosspiece 289 and located on each side plate in the second plane ofsymmetry are coaxial pivot holes 286 which are close fits to the twopivot pins 294 of the lens support assembly 240. Extendingperpendicularly to the flat crosspiece 289 in the second plane ofsymmetry and more offset from the crosspiece than the pivot holes 286are mirror image reaction slots 287, which are close sliding fits to thetwo traveling pins 293.

Coplanar inwardly extending mirror mounting tabs 288 extend inwardlyparallel to the crosspiece 289. Each tab 288 has a central mounting holefor the mirror 310, and the surfaces of the tabs opposed to thecrosspiece 289 are parallel. The separation of the tabs 288 is suchthat, when the mirror 310 is mounted thereon, the upper reflectivesurface of the mirror is coplanar with the axis of the pivot pins 294mounted in the pivot holes 286. Access holes are provided in thecrosspiece 289 coaxial with the mounting holes in the tabs 288 so thatthe mirror can be mounted to the tabs.

The mirror 310 is a thin planar rectangular metallic sheet having ahighly polished reflective upper surface and side notches to clear theheads of the pivot pins 294. Right circular cylindrical projections onthe lower face of the mirror 310 extend through the mounting holes inthe tabs 288 of the mirror carrier 285. These projections are peenedover to retain the mirror 310 on the mirror carrier.

Flat washers 290 and 292 and also stepped washers 291 are used in theassembly of the lens support assembly 240 to minimize friction betweenthe righthand and lefthand first and second links, 262, 268, 273, and278 respectively and the mirror carrier 285. The bore of the flat washer290 is a close fit to the outer diameter of the pivot pin 294. The boreof the flat washer 292 is a close fit to the outer diameter of thetraveling pin 293. The bore of the stepped washer 291 is a close fit tothe outer diameter of the traveling pin 293, while the diameter of thesmaller step of the stepped washer 291 is a sliding fit in the slots ofthe first and second links 262, 268, 273, and 278 and the mirror carrier285. Assembly of the linkage shown in FIG. 12 is primarily done usingthe pivot pins 294 and the traveling pins 293, along with the washers290 and 291. Both the pivot pins 294 and the traveling pins 293 arepeened over on both ends.

When the lens support assembly 240 is assembled, the first tubular lenshousing 260 is mounted to the first righthand 262 and the first lefthand278 links by means of rivets 305 engaged through the mounting holes 308on the flange 261 of the housing and the corresponding holes 265 of thefirst righthand link and the first lefthand link.

Next, starting on the near or right side of FIG. 12, a pivot pin 294 issequentially extended through pivot hole 263 of the first righthand link262, a flat washer 290, the pivot hole 271 of the second righthand link268, another flat washer 290, and then a pivot hole 286 of the mirrorcarrier 285, following which the ends of the cylindrical pins 294 arepeened over. The same procedure is then done on the far or left side ofFIG. 12 using the first lefthand 278 and second lefthand 273 links.

The next step for the components on the near side of FIG. 12 is toinsert a traveling pin 293 sequentially through a stepped washer 291,the reaction slot 266 of the first righthand link 262, a second steppedwasher 291, the reaction slot 272 of the second righthand link 268, athird stepped washer, the reaction slot 287 of the mirror carrier 285,and finally through a flat washer 292. The steps of the stepped washerare engaged with the sides of the reaction slots, following which thetraveling pin 293 is loosely peened over on both ends. The sameprocedure is then done on the far side of FIG. 12 using the firstlefthand 278, second lefthand 273 link, and the mirror carrier 285.

The final assembly for the rotatable viewing assembly 250 involvescombining the second lens housing, the righthand 251 and lefthand 255covers, and the lens support assembly 240. Referring to FIGS. 8 and 9,the covers 251 and 255 are placed with their circular bosses concentricwith the pivot pins 294 of the lens support assembly 240 and with theirmating faces lying on the midplane of symmetry of the lens supportassembly 240. At the same time, the end of the lens support assembly 240holding the second lens housing 260 is oriented so that it extendsthrough the cutout in the transverse end face 253 of the lefthand cover255 and the corresponding cutout of the righthand cover 251. Screws 312are then extended through the mounting holes 308 of the lens housing 260and the corresponding holes of the end faces of the covers 251 and 255,and there threadedly engaged with hex nuts 313. The hex nuts 313 are notshown in the illustrations for the third embodiment 200, but can be seenin FIG. 21, wherein the fourth embodiment 400 is illustrated. Fourthembodiment 400 utilizes the same rotatable viewing assembly 250 as doesthe third embodiment.

V. Fourth Embodiment of the Apparatus

The fourth embodiment 400 of the portable examination device is shown inFIGS. 18 to 22. This fourth embodiment utilizes all of the features ofthe third embodiment as well as including a means for electronicallycapturing and transmitting an image which can simultaneously be viewedby eye through the eyepiece lens. Because the housing 411 of the fourthembodiment 400 contains additional features beyond those for the housing211 of the third embodiment, the changes for housing 411 are discussedbelow.

The fiber optic system 170, the rotatable viewing assembly 250, thebattery 230, the switch 207, and the lens mounting block 450 with itsLED and lenses are common to both the third and fourth embodiments.Except as noted below, the two housing halves 412 and 422 aremirror-image parts which surround the internal components of theapparatus 400.

Details of the lefthand housing half 422 are shown in FIGS. 19, 20, and21. The lefthand housing half 422 is a thin wall body with a verticalouter wall offset from the midplane of the housing assembly and aperpendicular peripheral wall extending normal to the midplane of thehousing assembly 411. Housing half 422 has a vertical planar mating facecomatable with a corresponding face for righthand housing half 412 atthe midplane of the housing assembly. The perpendicular peripheral wallof housing half 422 has a horizontally elongated upper and lowerperimeter walls having a rear opening, an intermediate verticaltransverse diaphragm 427, and a vertical transverse forward end. Theheight of the righthand housing half 422 is reduced at its forward endby inclined flat transition sections, with the upper flat transitionsection extending approximately 40% of the length of the housing half.In the midsection of the lefthand housing half 422, the upper and lowerperipheral wall surfaces are parallel and horizontal. At its rear end,the upper and lower peripheral wall surfaces are also parallel, but areinclined upwardly towards the rear.

Offset from the mating face of the lefthand housing half 422 on itsforward section is a flat outer wall connected to the perpendicularperipheral wall. The distance between the mating face and the outer wallis less than the height of the lefthand housing half. As can be seenbest in FIG. 21, the lefthand housing half 422 is widened toward therear from the junction of the horizontal portion to the rearwardlyupwardly inclined portion of the upper and lower peripheral walls.

The rearward section of the housing half 422, consisting of about onethird of its length, has a vertical outer wall which is parallel to butoffset more from the vertical housing midplane than the forward end ofthe housing. The rearward section of the vertical outer wall is arcuatewith the axis of the arc horizontal and perpendicular to the midplane ofthe housing. Coaxial with the axis of the arc on the rearward section ofthe vertical outer wall is a transverse circular guide bore opening 423.The rearmost section of the vertical outer wall extends farther to therear than do the upper and lower peripheral walls of the lefthandhousing half 422.

As seen in FIG. 21, lefthand housing half 422 has a semicircular cutoutwand opening 424 on its forward vertical end which mounts an elastomericgrommet 75 which serves to centralize the fiber optic wand 170 where itpasses out of the housing 411. On the upper horizontal side of thehousing half 422 is located a rectangular cutout 433 for accommodatingthe switch 207 for the electric power.

As shown herein, the lefthand housing half 422 has on the inner side ofits peripheral walls multiple alignment bosses 426 which extendhorizontally past the vertical mating face of the housing half but whichdo not extend beyond the inner side of the peripheral wall in an outwarddirection. These alignment bosses 426 serve to maintain alignmentbetween the two housing halves 412 and 422. The alignment bossesrepresent the only departure from mirror imagery for the two housinghalves 412 and 422.

The mounting boss 436 for the beam splitter assembly is approximatelysquare in outline, extends towards the midplane of the housing 411, andhas its horizontal centerline aligned with the semicircular image fibercutout 428, described below. The mounting boss 436 has corner rims tolocate the beam splitter assembly 470.

The vertical transverse bulkhead 427 of housing half 422 is providedwith horizontal axis semicircular cutouts 409, 428 and 429 which havetheir axes on the mating plane of the housing half. Cutout 428 serves asa locator and passageway for the image fiber 172 and cutout 429 servesthe same purpose for the main fiber bundle 171 of the fiber opticassembly 170. Cutout 409 serves as a passage for one or more batterycables 231.

All of the semicircular cutouts 424, 409, 428, and 429 have the axes ofthe semicircles on the mating plane of the housing halves 412 and 422.Another semicircular cutout 430 is provided on the lower inclined faceof lefthand housing half 422, again with its axis perpendicular to thelower inclined face and located on the housing midplane. Cutout 430 is aclose fit to an image data plug 480.

Bosses are provided on the interior vertical faces of the flat outerwall to locate internal components housed within the housing 411. Forlefthand housing half 422, inwardly projecting boss 402 locates switch207, multiple bosses 403 locate the battery 230, and a low height boss404 extends inwardly above the interior horizontal lower wall of housing422 to locate the lens mounting block 450.

In addition, two restraining bosses 416 project from the interiorvertical wall towards the housing midplane symmetrically positionedabout a horizontal plane passing through the axis of guide bore opening423. The bosses 416 closely fit around the upper and lower edges of thefirst righthand link 262 of the lens support assembly 240 of therotatable viewing subassembly 250, thereby locating that assembly. Thecorresponding bosses of the righthand housing half 412 likewise closelyengage the upper and lower edges of the first lefthand link 278 of thelens support assembly 240 of the rotatable viewing subassembly 250.

Corresponding coaxial horizontal holes 437 and 432 penetrate thevertical outer walls of both the righthand 412 and lefthand 422 housinghalves, respectively. Hole 432 is hexagonal in order to closely engageand thereby provide rotational restraint for nut 87. These coaxial holespermit the housing screw 86 to extend through both holes and to thereengage housing nut 87 so that the housing halves can be assembled intoalignment and clamped together.

A beam splitting assembly 470 is shown in a longitudinal verticalcross-section in FIGS. 22-24. The beam splitting assembly 470 is shownin FIG. 22. The beam splitting assembly has a hollow cubic box body 471with a circular entry port 472 on a first vertical side, a circularthrough exit port 473 on a second vertical side opposed to the firstside, and a third CCD port 474 on its bottom side.

The first embodiment of the beam splitting assembly 470 shown in FIG. 22has a light filter 477 which passes only a selected range of incidentwavelengths mounted concentrically on the exterior side of the entryport 472. The second embodiment of the beam splitting assembly 470 shownin FIG. 23 has a light filter 498 which passes only a selected range ofincident wavelengths mounted concentrically on the exterior side of theexit port 473. The third embodiment of the beam splitting assembly 470shown in FIG. 24 has a light filter 489 which passes only a selectedrange of incident wavelengths mounted concentrically on the exteriorside of the CCD port 474. Different embodiments of the beam splittingassembly may have one, two or three light filters such that a filtercovers the entry port, the exit port, the CCD port, any two of theports, or all three of the ports.

An upper rectangular corner bracket boss 475 is located at theintersection of the top and first side, while a lower rectangular cornerbracket boss 475 is located at the intersection of the bottom and thesecond side. A diagonal groove extends through the corner bracket bosses475 from the corner of the first vertical side to the corner of thesecond vertical side and the bottom. The diagonal groove is inclinedabout 45° from the vertical.

A rectangular beam splitter 476 is mounted in the diagonal grooves ofthe corner bracket bosses 475 so that it is exposed to incident lightentering through the entry port 472 with or without an optional filter477 mounted thereon. The beam splitter 476 splits the light beamconditioned by the second lens unit 65 into two light beams. One lightbeam is directed to the ocular viewer 90 and the second beam is directedto an image capture device. Examples of a suitable beam splitter 476include without limitation a dichroic mirror, a half silvered mirror, ora polarization beam splitter.

A rectangular CCD imaging device or image capture device 478 is mountedto the bottom surface of the body 471 of the beam splitter assembly 470.The beam splitter 476 is selectively constructed to reflect certainincident wavelengths of light downwardly through the CCD port 474, whileit passes the remaining wavelengths of incident light through the beamsplitter 476 and out through the exit port 473 without reflection. Thelight reflected downwardly by the beam splitter 476 impinges on theupper, sensitive surface of the charge-coupled device (CCD) 478, wherebya pixelated electronically sensed image is gathered and transmitted to amulticonductor image data plug 480 by image data cable 481. If power isrequired for the CCD device 478, it can be delivered either by thebattery 230 or by means of the multiconductor image data plug 480 andimage data cable 481.

The beam splitter assembly 470 allows the operator of the examinationdevice to visualize the tissue and at the same time to capture an imageof the tissue 5. The beam splitter assembly 470 can be constructed suchthat the operator visualizes the same image as the image capture devicecaptures, or it can be constructed such that the operator visualizes adifferent image than captured by the image capture device. For example,the operator may visualize a reflected image of the tissue, while theCCD image capture device 478 captures an electronic image of tissueautoflourescence at a predetermined wavelength.

OPERATION OF THE APPARATUS EMBODIMENTS

The operation of the portable examination device will vary somewhatdepending on the components selected, the configuration of thecomponents, and the tissue to be examined.

By way of example, the portable examination devices of the first 10 andsecond 100 embodiments function in the following manner. Electricalpower is obtained from a wall outlet and is stepped down and rectifiedto a voltage suitable for the illumination source 2 or LED or laser 57.

The illumination source 2, such as the LED or laser 57, produces acharacteristic light spectrum beam 81 which may be conditioned by thelenses and/or filters of the first lens unit 60 prior to beingtransmitted into main fiber optic bundle 71. The embodiment illustratedin FIG. 26 uses a single filter/lens to condition the light beam 81,while the embodiment shown in FIGS. 3 and 4 uses both lenses and afilter to prepare the light used to illuminate the tissue 5. Any numberof filters and/or lenses may be used to condition the light beam 81.Examples of such filters and/or lenses include a polarizer, a neutraldensity filter, a fluorescent filter, or a collimating lens may be used.

For example, the first lens unit 60 illustrated in FIG. 4 collimates thelight beam 81 with lenses 62 and 63 and then filters the collimatedlight beam 81 with filter 64 coaxially mounted with the first lens unit60. The conditioned light beam 81 is then transmitted into the mainfiber optic bundle 71 of the fiber optic assembly 70 and directed towardthe biological tissue 5 located adjacent the outer end of the fiberoptic assembly 70. The second embodiment 100 operates in substantiallythe same way. The conditioned light beam 81 is similarly transmittedinto main fiber bundle 171 of the second embodiment 100 to be directedtoward the biological specimen of interest located adjacent the outerend of the fiber optic assembly 170.

Fluorescent and/or reflectance spectra are typically used tocharacterize the pre-cancerous or cancerous condition of the tissuebeing examined. One or more excitation fluorescence bandwidths may beused, such as 455-465 nm, 410-430 nm, 375-385 nm and/or 340-360 nm, toexcite the tissue. Similarly if reflectance is used to examine thetissue, then white light (400-700 nm), or narrower bands such as 455-465nm, 410-430 nm or 550-590 nm may be used to illuminate the tissue.Parallel and/or cross-polarized light may also be used to enhancedifferent tissue structures.

At times the second lens unit is configured to substantially block thewavelength band of light selected by the first lens unit. This isparticularly useful when the illuminating light beam is selected toexcite the autoflourescence of the tissue.

When the portable examination device is in clinical use, a close fittingtubular transparent disposable plastic sanitary sheath 76 for the firstembodiment 10 or sheath 176 for the second embodiment 100 is used. Thesheaths 76 and 176 have a thin transverse distal end interposed over thedistal end of the shaft of the fiber optic assembly for sanitaryreasons. The distal tip 77 of the sheath 76 or the distal tip 177 of thesheath 176 are used to contact the tissue of interest rather than thedistal end of the shaft of the fiber optic assembly. Using a disposablesheath helps to protect the fiber optic assembly, as well as helping toprevent the spreading of infectious agents from one patient to another.

The distal tip 77 of the sanitary sheath 76 is angled to direct specularreflection from the tissue/sheath interface away from the collectionpath. Furthermore, an optional lens or optical coupler 178 may beincorporated into the distal tip 77 of the sheath 76. If the distal tip77 has a lens/optical coupler 78 then the optical coupler 78 willcontact the tissue as part of the distal tip 77. Similarly, an optionallens or optical coupler 178 may be incorporated into the distal tip 177of the sheath 176. If the distal tip 177 has a lens/optical coupler 178then the optical coupler 178 will contact the tissue as part of thedistal tip 177.

The plastic of the disposable sanitary sheath is selected so that it istransparent to the wavelength band of light used to illuminate thesample, as well as the wavelength band of light used to visualize theilluminated tissue. Furthermore, the plastic of the sheath must notautofluoresce or otherwise interfere with the optics and spectralcharacteristics necessary for the optimal operation of the examinationdevice.

The light beam 82 emanating from the illuminated tissue 5 has adifferent spectral content that the incident light, depending on thecharacter of the cells illuminated in the specimen. Typically, a liquidcontrast agent is applied to the specimen prior to examination with theportable examination device of the present invention. The contrast agenteither alters the light reflectance of any cells of interest in thespecimen or causes them to fluoresce. Other contrast agents may beconfigured to bind to specific molecules on cell surfaces such asproteins or receptors.

The reflected or fluoresced light is transmitted by the image fiber 72or 172 to an ocular viewer. The light beam 82 may be conditioned, forexample collimated and filtered, by the second lens set 65 before beingdirected to the ocular viewer 90, where it is viewed by the operator ofthe examination device.

The third 200 and fourth 400 embodiments of the present inventionfunction in substantially the same manner as the first two embodiments10 and 100, but the embodiments 200 and 400 are both provided with anoperator adjustable mirror mechanism, the rotatable viewing subassembly250, which permits the operator to view the specimen image from aposition off the axis of the housing and fiber optic assembly 170.

For the third and fourth embodiments 200 and 400, the light from theillumination source or LED 57 is transmitted as light beam 295 to thetissue to be examined. The returning light is conditioned by the secondlens unit 65. When the light beam 296 emerges from the second lens unit65, it is directed at a mirror 310. The mirror 310 is mounted in a lenssupport assembly 240 which can selectably swivel the second outlet lenshousing or holder 260 through a variety of angles while holding thefirst inlet lens housing 260 static. Thus, the mirror 310 is caused torotate half as much by the lens support assembly 240 as the secondoutlet lens holder 260 so that the light beam 296 impinging on themirror 310 is directed as light beam 297 to the second lens housing 260and the ocular viewer 90 mounted thereon. The ocular viewer is angularlyadjustable up to 90° from the axis of the second lens unit 65.

The fourth embodiment 400 of the present invention interposes a beamsplitter assembly 470 between the second lens unit 65 and the selectablyrotatable mirror 310 of the rotatable viewing subassembly 250. The beamsplitter 476 reflects a certain wavelength band of incident light 492onto a CCD imaging device 478, while passing the remnant of incidentlight 493 through the beam splitter 476 without reflection to the mirror310 of the rotatable viewing subassembly 250 and then to the operatorthrough viewing lens 90. Since a portion of the light beam 491 emanatingfrom the illuminated tissue is reflected onto the CCD imaging device,the operator is permitted to capture an electronic image of the sametissue as being viewed by the operator. The electronically capturedimage can be electronically stored, enlarged, viewed, and/or spectrallyanalyzed at any time on an external viewer, processor, and/or computer.

Although the present invention and its advantages have been described indetail, it should be understood that various changes, substitutions andalterations can be made herein without departing from the spirit andscope of the invention as defined by the appended claims.

What is claimed is:
 1. A medical examination device for spectrallyscreening tissue for cancer having: an illumination source transmittinga light beam through a first lens unit to condition the light beam; afiber optic bundle including an excitation fiber and an image fiber,wherein the excitation fiber delivers the conditioned light beam fromthe first lens unit to a tissue to be examined and wherein the imagefiber directs a light emanating from an illuminated tissue to a secondlens unit; an angularly adjustable visualization unit having a pivotablelinkage with a first lens holder mounted on a first end of the pivotablelinkage, a second lens holder mounted on a second end of the pivotablelinkage, a pivoting mechanism positioned between the first and secondends of the linkage that allows an operator to adjust an angle of thefirst lens holder in relationship to the second lens holder, and amirror rotatably supported by the pivotable linkage proximal thepivoting mechanism such that a light beam conditioned by the second lensunit passes through the angularly adjustable visualization unit and isvisualized by the device operator through a lens mounted in a secondlens holder and wherein the first lens holder is held in an alignedposition that is coaxially aligned with the second lens unit while themirror and the second lens holder are angularly adjustable about thealigned position.
 2. The medical examination device of claim 1, whereinthe angularly adjustable visualization unit includes an ocular viewerand an image capture device.
 3. The medical examination device of claim2, wherein the angularly adjustable visualization unit includes a beamsplitter between the second lens unit and the ocular viewer.
 4. Themedical examination device of claim 3, wherein the beam splitter splitsa light conditioned by the second lens unit into two light beams withone light beam directed to the ocular viewer and a second beam of lightdirected to the image capture device.
 5. The medical examination deviceof claim 4, wherein the beam splitter is a dichroic mirror.
 6. Themedical examination device of claim 1, wherein the first lens unitincludes a collimating lens.
 7. The medical examination device of claim1, wherein the first lens unit includes a lens or a filter.
 8. Themedical examination device of claim 1, wherein the first lens unitincludes as polarizing filter.
 9. The medical examination device ofclaim 1, wherein the first lens unit selects a wavelength band of455-465 nm, 410-465 nm, 375-385 nm, or 340-360 nm.
 10. The medicalexamination device of claim 1, further comprising a disposable sheathfor covering the fiber optic bundle.
 11. The medical examination deviceof claim 10, wherein the disposable sheath has a transverse distal endfor contacting the tissue to be examined.
 12. The medical examinationdevice of claim 1, wherein as distal end of the fiber optic bundle isangled.
 13. The medical examination device of claim 12, furthercomprising an angled disposable sheath for covering the distal end ofthe fiber optic bundle.
 14. The medical examination device of claim 1,wherein the first lens holder is angularly adjustable up to a 90° anglefrom a position coaxially aligned with the second lens unit.
 15. Themedical examination device of claim 1, wherein the pivotable linkageincluding a first side having a first and a second link and a secondside having a first and a second link.
 16. The medical examinationdevice of claim 15, wherein the first lens holder is mounted on aproximal end of the second link of the first side and a proximal end ofthe second link of the second side and the second lens holder mounted ona distal end of the first link of the first side and a distal end of thefirst link of the second side and wherein the pivoting mechanisminterconnects the first and second sides of the pivotable linkagebetween the first and second lens holders.
 17. The medical examinationdevice of claim 15, wherein the pivoting mechanism includes a reactionslot in the first and second sides of the pivotable linkage connectedwith a slideable traveling pin passing through the reaction slot of thefirst and second sides of the pivotable linkage.
 18. The medicalexamination device of claim 1, wherein a mirror carrier is angularlyadjusted by the angular adjustment of the second lens holder such thatthe second light beam is reflected off the mirrored surface to thesecond lens holder whenever the second lens holder is angularly adjustedto be out of alignment with the second lens unit.
 19. A medicalexamination device for spectral detection of cancer having: anillumination source; a first lens unit conditioning a light beam fromthe illumination source; an excitation optic fiber deliveringconditioned light beam from the first lens unit to a tissue to beexamined; an image optic fiber receiving a light beam emanating from atissue illuminated with a conditioned light beam and transmitting aemanated light beam through a second lens unit; and a viewing assemblyhaving a pivotable linkage including a first side having a first andsecond link and a second side having a first and second link, a firstlens holder mounted on a proximal end of the second link of the firstside and a proximal end of the second link of the second side, a secondlens holder mounted on a distal end of the first link of the first sideand a distal end of the first link of the second side, a pivotingmechanism interconnecting the first and second sides of the pivotablelinkage wherein the pivoting mechanism allows an operator to adjust aangle of the first lens holder in relationship to the second lensholder, and a mirror carrier having a mirrored surface rotatablysupported by an interior end of the first and second links of the firstand second sides proximal the pivoting mechanism, wherein the first lensholder is held in an aligned position that is coaxially aligned with thesecond lens unit while the mirror carrier and the second lens holder areangularly adjustable about the aligned position; and whereby theemanating light beam passing through the second lens unit is directedthrough the viewing assembly.
 20. The medical examination device ofclaim 19, wherein the image optic fiber is a coherent fiber opticbundle.
 21. The medical examination device of claim 19, furthercomprising a beam splitter and an image capture device.
 22. The medicalexamination device of claim 21, wherein the beam splitter is positionedbetween the second lens unit and the viewing assembly.
 23. The medicalexamination device of claim 21, wherein the beam splitter splits thelight passing through the second lens unit into two light beams with onelight beam directed through the viewing assembly and a second beam oflight directed to the image capture device.
 24. The medical examinationdevice of claim 19, wherein the first lens unit includes a collimatinglens.
 25. The medical examination device of claim 19, wherein the firstlens unit selects a wavelength band of 455-465 nm, 410-465 nm, 375-385nm, or 340-360 nm.
 26. The medical examination device of claim 25,wherein the second lens unit substantially blocks the wavelength bandselected by the first lens unit.
 27. The medical examination device ofclaim 19, further comprising a disposable sheath for covering a distalend of the excitation optic fiber and a distal end of the image opticfiber.
 28. The medical examination device of claim 27, wherein thedisposable sheath is angled at the distal end.
 29. The medicalexamination device of claim 27, wherein the disposable sheath has anoptical coupler incorporated in the distal end.
 30. The medicalexamination device of claim 19, wherein the second lens holder isangularly adjustable up to a 90° angle from the aligned position.
 31. Amedical examination device having: an illumination source; a first lensunit conditioning a light beam from a illumination source; an excitationoptic fiber delivering a conditioned light beam from the first lens unitto a tissue to be examined; an image optic fiber receiving a light beamemanating from a tissue illuminated with a conditioned light beam andtransmitting the emanated light beam through a second lens unit; a beamsplitter that splits the emanated light beam from the second lens unitinto a first light beam and a second light beam; an image capture devicefor selectably capturing the first light beam; and a viewing assemblyhaving a pivotable linkage including a first side having a first andsecond link and a second side having a first and second link, a firstlens holder mounted on a proximal end of the second link of the firstside and a proximal end of the second link of the second side, a secondlens holder mounted on a distal end of the first link of the first sideand a distal end of the first link of the second side, a pivotingmechanism interconnecting the first and second sides of the linkagebetween the first and second lens holders wherein the pivoting mechanismallows an operator to adjust the angle of the first lens holder inrelationship to the second lens holder, and a mirror carrier having amirrored surface is rotatably supported by an interior end of the firstand second links of the first and second sides proximal the pivotingmechanism, wherein the first lens holder is held in an aligned positionthat is coaxially aligned with the second lens unit while the mirror andthe second lens holder are angularly adjustable about the alignedposition; and wherein the second light beam is directed through theviewing assembly to a lens mounted in the second lens holder forvisualization of the second light beam by the operator.
 32. The medicalexamination device of claim 31, wherein the mirror carrier is angularlyadjusted by the angular adjustment of the second lens holder such thatthe second light beam is reflected off the mirrored surface to thesecond lens holder whenever the second lens holder is angularly adjustedto be out of alignment with the second lens unit.
 33. The medicalexamination device of claim 31, wherein the first lens unit selects awavelength band of 455-465 nm, 410-465 nm, 375-385 nm, or 340-360 nm.34. The medical examination device of claim 33, wherein the second lensunit substantially blocks the wavelength band selected by the first lensunit.
 35. The medical examination device of claim 31, further comprisinga disposable sheath for covering a distal end of the excitation opticfiber and a distal end of the image optic fiber.
 36. The medicalexamination device of claim 35, wherein the disposable sheath is angledat the distal end.
 37. The medical examination device of claim 35,wherein the disposable sheath has an optical coupler incorporated in thedistal end.
 38. The medical examination device of claim 35, wherein thedisposable sheath has a transverse distal end for contacting the tissue.39. The medical examination device of claim 31, wherein the second lensholder is angularly adjustable up to a 90° angle from the alignedposition.